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December 10, 2008

Separating myth and evidence about electronic medical records

A national patient registry. National health information technology (HIT). Electronic medical records (EMR). These are all terms for a nationalized electronic system that connects government agencies, insurers, prescription benefit managers and healthcare providers, enabling seamless access and sharing of our medical records.

It’s been widely promoted that electronic medical records will lead to significant healthcare savings and improve the accuracy of communications among care providers, reduce medical errors, improve health and save lives. But few consumers have looked past the claims to examine the evidence. Is there any evidence to support claims that EMRs will save billions of dollars and improve patient outcomes?

Popular misperceptions of the efficiency of EMRs versus the reality for healthcare professionals, as we’ve seen, may be why claims of benefits seem so plausible. For doctors and nurses charting patient assessments, care and prescriptions, however, clicking through computer pages to select the appropriate standardized boxes and responding to each electronic prompt are cumbersome and add little quality, individuality or accuracy to communications among care providers.

The core of suggested health benefits of EMRs linked to a national central database is that they improve quality of care through improved adherence to pay-for-performance measures issued by third-party payers (eg. government). P4p measures, however, have continued to fail to equate to improved clinical outcomes for many patients or to result in cost savings. So, not unexpectedly, EMRs haven’t yet shown to improve clinical outcomes better than paper systems.

Two recent studies

Two recent studies examining whether EMRs improve clinical care received little media attention. The first study was by cardiologists with the IMPROVE-HR study and led by Dr. Mary Norine Walsh, M.D., FACC, President of the Indiana Chapter of the American College of Cardiology and director of nuclear cardiology and congestive heart failure at St. Vincent Hospital in Indianapolis. They noted that there is a dearth of data demonstrating benefits of EMRs for improving quality of care. So, they evaluated the effects of EMRs over paper records in the care received by 15,381 heart failure patients in the IMPROVE-HF study cohort. They noted that their study was among the first to assess contemporary EMR platforms.

They compared care among 87 clinical practices using EMRs versus 80 that used paper records. Their findings showed no improvement in the quality of care the heart patients received, based on seven evidence-based guidelines, using EMRs as compared to paper-based systems. Controlling for characteristics of the clinical sites (size, region, teaching facility, specialty services, etc.), only one measure rated better among the sites that had adopted electronic records: documentatation of distributing education material.

As Dr. Walsh toldModern Medicine, their findings are consistent with a recent U.S. 2008 Health Information Technology study “that found no significant association between electronic health record use and quality of care.” The use of EMRs, themselves, does not improve the quality of care for heart patients, she said.

Another study, published in Archives of Internal Medicine, was led by Dr. Jeffrey A. Linder, M.D., MPH, at Brigham and Women's Hospital and Harvard Medical School in Boston, Massachusetts. This study assessed if EMRs improved the quality of ambulatory care received by patients at physician offices, clinics and outpatient hospital departments. Among the 17 measures they used were appropriate prescribing of antibiotics and medications in elderly patients. Evaluating an estimated 1.8 billion ambulatory visits by patients in the United States in 2003 and 2004, they found no statistical difference in 14 of 17 quality indicators among sites with electronic versus paper records. Only two measures showed nominally better performance: 7% more avoided benzodiazepine (tranquilizers such as valium and xanax) for depression, and 3% more avoided routine urinalyses. One measure was worse, with 14% fewer adhering to prescribing statins for high cholesterol. The authors concluded that EMRs were not associated with better quality ambulatory care.

Potential versus demonstrated benefits

As unimpressive as these studies were in improving quality, even as measured by adherence to P4P measures, it might be tempting to believe there must be a body of credible evidence that EMRs improve health outcomes. But as a 2005 RAND HIT Project report, sponsored by industry stakeholders in EMRs, acknowledged, “the literature provides little evidence about EMR systems’ effects on health.”

Claims of benefits are based on theorized effects in both how and how well electronic records might work. Specifically, in suggesting benefits, RAND used the word “potential.” EMRs were first assumed to be widely adopted and effective, then computer modeling estimated the potential health benefits based on two key features they said can be exploited with EMR systems: compliance with preventive health and disease management. EMR systems can integrate preventive care measures, such as screenings, with patient data such as age, gender, family history and lifestyle habits, they said, to identify patients needing intervention, track their use of preventive services and remind doctors to provide tests. Disease management programs identify people with a potential or active chronic disease, target services to them based on their level of risk, monitor their condition and attempt to modify their behavior, they added.

Their model “assumed that the services are rendered to 100% of people not currently complying with the U.S. Preventive Services Task Force recommendation” and that the health benefits are significant. Based on beliefs that major chronic diseases of aging are preventable, the purported benefits of preventive health and wellness measures were largely attributed to EMRs, rather than comparing other less invasive or costly methods to promote, for example, immunizations or cancer screenings.

“Using our MEPS-based model, we estimated how combinations of lifestyle changes and medications that reduced the incidence of these conditions would affect health care use, spending, and outcomes,” they wrote. Never the less, their model found that while hospital use was reduced with EMRs, physician office visits and use of prescription drugs increased.

Changing and complex regulations

Not only do performance measures and regulations continually change, but electronic medical systems are becoming more complicated for providers, even down to the proper coding of patient diagnoses and treatments in order to receive reimbursement from third-party payers. The government has proposed a new International Classification of Diseases (ICD-10), with all providers to be compliant in 2011. This new government mandate, alone, will require every doctor and healthcare provider to change their medical record systems at an estimated cost of $83,290 for a small practice of just three doctors to $2.7 million for larger clinical practices with 100 doctors, as well as retrain staff and increase each doctor’s workload by up to 4%, according to a cost analysis conduction by a coalition of organizations, including the AMA, the Medical Group Management Association, the American College of Physicians, the American Academy of Professional Coders, and others.

The Centers for Medicare and Medicaid Services (CMS), the federal agency that maintains medical codes, says the new system will allow doctors to include more details on patients’ medical records. As the Wall Street Journal reported last month: “CMS estimates additional costs to the medical industry of adopting the new coding system of $1.64 billion over 15 years.”

For an idea of how challenging charting will become for doctors, the new system includes 155,000 codes, including an increase in the number of diagnoses to 68,000 from the current 13,500. To document medical procedures, doctors will have to check the correct code from among 87,000 options, compared to the 3,000 in the current system. Some suggest this is mostly to benefit government oversight of providers but its complexity and real-world practicality will also increase billing and coding errors. This is just one example to illustrate that increased documentation is not equivalent to improved quality of patient care.

Will having 45 codes for a sprained ankle, rather than the current five, really improve patient outcomes?

Body of evidence for EMRs

Two major reviews of the evidence for health benefits of EMRs have been published to date. In the first, researchers at the University of Toronto, Ontario, conducted a systematic review of randomized controlled trials published from 1966 through September 2005 that evaluated the effects on doctors performance or patient outcomes for hand-held EMRs (PDAs) compared to paper medical records and desktop EMRs. They “found no primary or secondary outcomes evaluating changes in reviewing information, ordering by clinicians or improvement in patient care.” Incredibly, they found only two studies, both methodologically strong, which examined the care of orthopedic patients using hand-held, portable computerized EMRs.

Both studies found EMRs resulted in more documentation but increased charting time required for providers and increased wrong or redundant diagnoses. No research has measured clinical outcomes and there is currently little evidence to support the effectiveness of EMRs for improving documentation, reducing medical errors or improving clinical decisions, the Toronto authors said. “This highlights another area where informatics interventions are being implemented widely without rigorous evaluation,” they concluded.

A second review published this summer in the International Journal of Medical Informatics, evaluated the evidence for EMRs in primary care. This comprehensive systematic review examined nearly 3,700 articles published from seven countries, as well as 22 government/commissions. A total of 86 articles met their criteria of examining quality of care, patient safety or outcomes. End users of EMRs had raised concerns about their effects on patient privacy, patient safety, doctor-patient relationships, staff anxiety, time factors, quality of care, finances, efficiency and liability, they stated.

Their review found that the implementation of EMRs had no affect in improving quality of care, patient safety or provider-patient relationships. The fact that no published research has shown benefits to patients of EMR over paper systems, they concluded, should be a concern to adopters, payers and jurisdictions.

So, claims that electronic medical records, interconnected across the country, will save lives is based on no evidence. But it comes at considerable costs. We’ll examine those next.